NCT06081959 Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
| NCT ID | NCT06081959 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 376 participants |
| Start Date | 2023-10-31 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 376 participants in total. It began in 2023-10-31 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
Eligibility Criteria
Inclusion Criteria: * Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF; * Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples; * Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage; * Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; * Expected survival ≥ 12 weeks; * Adequate organ and bone marrow function; * Patients who are eligible for a chemotherapy regimen in the control group; * Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose; * Patients who voluntarily participate in the study and sign the ICF, and able to comply with the visit and related procedures stipulated in the plan. Exclusion Criteria: * Patients with a history of central nervous system (CNS) metastases or current CNS metastases； * Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the first dose; * Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors may affect investigational treatment; * Uncontrollable systemic diseases assessed by the investigator; * History of (noninfectious) interstitial lung disease (ILD)/noninfectious neumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging; * Clinically serious lung injuries caused by lung diseases; * Patients with active chronic Inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding; * Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1; * Active hepatitis B or hepatitis C; * Human immunodeficiency virus (HIV) antibody test positive or a history of acquired immunodeficiency syndrome (AIDS), known active syphilis infection; * Known allergy or hypersensitivity to SKB264, or the excipients of SKB264; * Prior TROP2 targeted therapy, prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy; * Patients who received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ; * Patients with concomitant infections requiring systemic antibiotic therapy within 2 week prior to the first dose of study treatment; * Patients who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study; * Pregnant or lactating women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06081959 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06081959 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 376 participants.
Is NCT06081959 currently recruiting?
Yes, NCT06081959 is actively recruiting participants. Contact the research team at diaoyina@kelun.com for enrollment information.
Where is the NCT06081959 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06081959 clinical trial?
NCT06081959 is sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. The trial plans to enroll 376 participants.
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